PUSEN

GUDID 06973356557891

Shenzhen Trious Medical Technology Co., Ltd.

Endoscopic-access dilator, single-use

• Primary Device ID: 06973356557891
• NIH Device Record Key: 79b35c11-8a28-4ae5-8f94-27d6140bd80c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PUSEN
• Version Model Number: 205W12F50
• Company DUNS: 698045520
• Company Name: Shenzhen Trious Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973356557891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243710

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-16
• Device Publish Date: 2025-12-08

On-Brand Devices [PUSEN]

• 06973356557907: 104F150PS
• 06973356557891: 205W12F50
• 06973356557884: 205W12F40
• 06973356557877: 205W11F50
• 06973356557860: 205W11F40
• 06973356557853: 205W10F50
• 06973356557846: 205W10F40